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(Swedesboro NJ, December 12, 2007) Yesterday, the U.S. Court of Appeals for the District of Columbia Circuit vacated the Drug Enforcement Administration’s (DEA) 2006 revocation of Wedgewood Pharmacy’s registration to dispense controlled substances. Wedgewood has been challenging the DEA’s decision since it first was issued.
The ruling consolidated two petitions: the company’s appeal of the DEA’s decision and the DEA’s denial of Wedgewood’s petition for reconsideration. The court explained that it does not set-aside Federal agency rulings “unless the interpretation is arbitrary, capricious, or manifestly contrary to the statute . . . [and] if the agency . . . entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.” The unanimous ruling, authored by Circuit Judge Karen LeCraft Henderson, noted “we cannot help but conclude that the DA’s [DEA’s Deputy Administrator] decision ‘entirely failed to consider an important aspect of the problem,’” that is, “whether animal medicine operates differently from human medicine.”
George J. Malmberg, R.Ph., F.A.C.A, F.A.C.V.P., the pharmacist president and CEO of Wedgewood Pharmacy, noted: “The Court made clear its concern that the practice of veterinary medicine differs from the practice of human medicine. We believe that the current standard of practice in our profession, which is to dispense controlled substances to veterinarians rather than to horse owners or stable personnel, is consistent with the law’s intention to prevent the improper use of controlled substances. We look forward to having our registration restored by the DEA, though the timing of that will depend upon the agency’s response to this ruling.”
The DEA objected to Wedgewood’s practice of preparing compounded controlled-substances and then delivering the medications to veterinarians and physicians instead of directly to their patients. DEA viewed these practices as “manufacturing” and “distributing” controlled substances as defined by the Controlled Substances Act. Under Wedgewood’s then DEA-registration as a “practitioner,” however, it was authorized only to “compound” and “dispense” controlled substances. Wedgewood argued that “dispensing” includes constructive delivery to an animal patient through a licensed veterinarian.
In vacating the revocation of Wedgewood’s registration to dispense controlled substances, the court remanded the case to the DEA “for further proceedings consistent with this order,” saying that the “DEA should clarify its interpretation of ‘general office use,’ ‘order’ and ‘prescription’” and that the agency should “explain how the difference, if any, between the practices of human and veterinary medicine might affect its analysis.”
Malmberg added, “This ruling tells us that we were correct in making arguments that the DEA rejected or ignored. We welcome the opportunity that this ruling now creates to arrive at a clear, sound understanding that works for all concerned. We want nothing more than to work cooperatively with DEA to resolve any issues it may still have with the current state of compounding- pharmacy practice in the veterinary profession.”
The court decision is available at http://pacer.cadc.uscourts.gov/docs/common/opinions/200712/06-1156a.pdf.
A compounding pharmacy creates customized medications for individual patients in response to a licensed practitioner’s prescription. Wedgewood Pharmacy is one of the largest compounding pharmacies in the United States, serving more than 25,000 prescribers of compounded medications. It is located in Swedesboro NJ and licensed throughout the United States.
Because every patient is different and has different needs, customized, compounded medications are a vital part of quality medical care. The basis of the profession of pharmacy has always been the "triad," the patient-prescriber-pharmacist relationship.
Through this relationship, patient needs are determined by a prescriber, who chooses a treatment regimen that may include a compounded medication. Prescribers often prescribe compounded medications for reasons that include (but are not limited to) the following situations:
For additional information, visit the International Academy of Compounding Pharmacists’ Web site at www.iacprx.org and www.compoundingfacts.org.
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This content is intended for counseling purposes only. This content is informational/educational and is not intended to treat or diagnose any disease or patient. No claims are made as to the safety or efficacy of mentioned preparations. The compounded medications featured in this content have been prescribed and/or administered by prescribers who work with Wedgewood Pharmacy. You are encouraged to speak with your prescriber as to the appropriate use of any medication. Wedgewood Pharmacy’s compounded veterinary preparations are not intended for use in food and food-producing animals. All product and company names are trademarks™ or registered® trademarks of their respective holders. Use of them does not imply any affiliation with or endorsement by them.